Actively Recruiting
Maintenance Pembrolizumab at Usual or Low doSE in Non-squamous Lung Cancer: a Non-inferiority Study
Led by Gustave Roussy, Cancer Campus, Grand Paris · Updated on 2025-06-25
1166
Participants Needed
37
Research Sites
302 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Pulse is a randomized non-inferiority phase III clinical trial assessing a new mode of immunotherapy administration based on increased interval time between 2 infusions as maintenance treatment in Pulse arm compared with the conventional administration in Control arm. In both treatment arms, pembrolizumab alone or combined with pemetrexed is allowed as maintenance treatment. Indeed : In Pulse arm : Pembrolizumab 200 mg will be administered to patients every 6 weeks (Q6W) plus, in the absence of contra-indication pemetrexed 500 mg/m\^2 will be administered every 3 weeks (Q3W). In control arm : Pembrolizumab 200 mg will be administered to patients every 3 weeks (Q3W) or 400 mg every 6 weeks plus,in the absence of contra-indication pemetrexed 500 mg/m\^2 will be administered every 3 weeks (Q3W).
CONDITIONS
Official Title
Maintenance Pembrolizumab at Usual or Low doSE in Non-squamous Lung Cancer: a Non-inferiority Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed diagnosis of non-squamous non-small cell lung cancer (NSCLC).
- Non-operable / non-irradiable stage III or stage IV.
- Eligible to receive 3 or 4 cycles of induction treatment with pembrolizumab plus platinum (cisplatin or carboplatin) and pemetrexed.
- For patients with EGFR mutation, ALK or ROS1 rearrangement, received at least one specific targeted therapy line.
- Age 18 years or older.
- Performance status 0 or 1.
- Signed informed consent.
- Affiliated with a social security system or beneficiary of the same.
- Received 3 or 4 cycles of induction treatment with pembrolizumab plus platinum and pemetrexed before maintenance phase.
- Last induction chemotherapy cycle within 42 days before randomization.
- Stable disease, partial or complete response after induction chemotherapy and pembrolizumab.
- Patients with stable or no progression brain metastases and clinically stable.
- Creatinine clearance greater than 30 ml/min if receiving pembrolizumab alone and greater than or equal to 45 ml/min if receiving pemetrexed plus pembrolizumab.
- Neutrophils count of at least 1500/µL and platelets at least 100,000/µL.
- Bilirubin less than or equal to 1.5 times the upper limit of normal.
- Liver enzymes (transaminases, alkaline phosphatase) less than or equal to 2.5 times the upper limit of normal except in case of liver metastases (up to 5 times).
- Prior platinum-based chemotherapy ended more than 6 months before induction chemotherapy for advanced stage.
- Prior immune checkpoint inhibitors finished at least 12 months before induction chemotherapy for advanced stage.
- Women no longer likely to procreate or using effective contraception; men using condoms and partners using contraception.
- Post-menopausal women meeting specific hormone criteria.
You will not qualify if you...
- Mixed small-cell or squamous-cell carcinoma.
- Mental or psychological illness preventing informed consent.
- Pregnant or breastfeeding women.
- History of HIV or chronic hepatitis B or C.
- Active or uncontrolled infection.
- Recent serious cardiovascular disorders within 6 months including bypass, angioplasty, myocardial infarction, severe angina, peripheral vascular disease, pulmonary embolism, stroke, or heart failure class III or IV.
- Participation in another experimental treatment or clinical trial.
- Grade 3 or 4 toxicity related to pembrolizumab limiting treatment continuation.
- Corticosteroid use above 20 mg prednisone or equivalent daily.
- Inability to follow therapeutic program.
- Ongoing immunosuppressive systemic therapy.
- Active autoimmune diseases except stable autoimmune hypothyroidism or insulin-treated diabetes.
- History of idiopathic pulmonary fibrosis, organized pneumonia, drug-induced lung disease, or active pneumonia or pulmonary infiltration.
- History of other malignancies unless in remission for at least 2 years without specific treatment, except certain low-risk cancers.
- Conditions making participation unsafe or compliance difficult.
- Live attenuated vaccine within 4 weeks before treatment or planned during study (flu vaccine allowed during season).
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 37 locations
1
CHU UCL Namur - Site Sainte Elisabeth
Namur, Belgium, B-5000
Actively Recruiting
2
Centre Hospitalier de Carcassonne
Carcassonne, Aude, France, 11810
Actively Recruiting
3
Clinique Sainte Anne - Strasbourg
Strasbourg, Bas-Rhin, France, 67000
Actively Recruiting
4
Institut de Cancérologie Strasbourg Europe (ICANS)
Strasbourg, Bas-Rhin, France, 67200
Actively Recruiting
5
Hôpital Européen de Marseille
Marseille, Bouches-du-Rhône, France, 13003
Actively Recruiting
6
Groupe Hospitalier La Rochelle
La Rochelle, Charente-Maritime, France, 17000
Actively Recruiting
7
Centre Hospitalier Régional Universitaire de Brest (Hôpital Morvan)
Brest, Finistère, France, 29609
Actively Recruiting
8
Centre Hospitalier des Pays de Morlaix
Morlaix, Finistère, France, 29600
Actively Recruiting
9
Groupe Hospitalier de la Région de Mulhouse et Sud Alsace
Mulhouse, Haut-Rhin, France, 68100
Actively Recruiting
10
Centre Hospitalier de Bigorre
Tarbes, Hautes-Pyrénées, France, 65000
Actively Recruiting
11
Hôpital Foch
Suresnes, Hauts-de-Seine, France, 92150
Actively Recruiting
12
Centre Hospitalier de Béziers
Béziers, Hérault, France, 34500
Actively Recruiting
13
CHU Rennes
Rennes, Ille-et-Vilaine, France, 35000
Actively Recruiting
14
Centre Hospitalier de Saint-Malo
St-Malo, Ille-et-Vilaine, France, 35400
Actively Recruiting
15
Centre Hospitalier Régional Universitaire de Tours
Tours, Indre-et-Loire, France, 37044
Actively Recruiting
16
Centre Hospitalier Universitaire - La Réunion - Site Felix Guyon
Saint-Denis, La Réunion, France, 97400
Not Yet Recruiting
17
Centre Hospitalier Universitaire - La Réunion - Site Sud
Saint-Pierre, La Réunion, France, 97448
Not Yet Recruiting
18
Centre Hospitalier Régional d'Orléans - NHO
Orléans, Loiret, France, 45067
Actively Recruiting
19
Hospices Civils de Lyon - Hôpital Louis Pradel
Bron, Lyon, France, 69677
Actively Recruiting
20
Centre Hospitalier de Cholet
Cholet, Maine-et-Loire, France, 49300
Actively Recruiting
21
Centre Hospitalier Intercommunal de Compiègne-Noyon
Compiègne, Oise, France, 60200
Actively Recruiting
22
CHU St-Etienne
Saint Priest En Jarez, Pays de la Loire Region, France, 42270
Actively Recruiting
23
Centre Hospitalier de la Côte Basque
Bayonne, Pyrénées-Atlantiques, France, 64100
Actively Recruiting
24
Centre Hospitalier Intercommunal Créteil
Créteil, Val-de-Marne, France, 94010
Actively Recruiting
25
Hôpital d'Instruction des Armées Bégin
Saint-Mandé, Val-de-Marne, France, 94160
Actively Recruiting
26
Institut Gustave Roussy
Villejuif, Val-de-Marne, France, 94 805
Actively Recruiting
27
Centre Hospitalier d'Auxerre
Auxerre, Yonne, France, 89000
Actively Recruiting
28
Hôpital Pitié-Salpêtrière - APHP
Paris, France, 75013
Actively Recruiting
29
Hôpital Cochin - APHP
Paris, France, 75014
Actively Recruiting
30
Hôpital Tenon - APHP
Paris, France, 75020
Actively Recruiting
31
Hôpital Paris Saint-Joseph
Paris, France, 75674
Actively Recruiting
32
H. Santa Creu i Sant Pau
Barcelona, Spain, 08025
Actively Recruiting
33
Vall d'Hebron Institute of Oncology (VHIO)
Barcelona, Spain, 08035
Actively Recruiting
34
H. Clinico San Carlos
Madrid, Spain, 28040
Actively Recruiting
35
HU. 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
36
Hospital Virgen de la Victoria
Málaga, Spain, 29010
Actively Recruiting
37
H.Virgen del Rocio
Seville, Spain, 41013
Actively Recruiting
Research Team
B
Benjamin BESSE
CONTACT
L
Lynda MATI
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here